FDA Inspection 736117 — Miracles In Sight Lone Star Division
The FDA completed an inspection of Miracles In Sight Lone Star Division on Jul 25, 2011 in Manor, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Manor, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |